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Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Machine Vision, Lasers, Laser-based Systems, Laser process, Light Processing, Optical Testing, Optics, Automation, Machine Design
Expert has developed automated inspection systems for various industries, that is, those systems needed for intermediate process control, as well as for final inspections. He is experienced with vision resolutions up to 4K by 4k with speeds up to 60…
Electronic and Mechanical Design of Consumer and Healthcare Products for Asian Manufacture
Expert has a biomedical engineering degree from MIT (option of electrical engineering). He was instrumental in the development of an acoustic-based diagnostic instrument for the detection of otitis media (fluid in the ear due to ear infection). The product was…
Embedded Systems, Communications, Sensors, Signal Processing, Power Control, Diagnostics
Expert has developed hybrid electric vehicles, vehicle-based power systems, automotive controls, engine controls, flight controls, and propulsion control systems for aircraft, automotive, locomotive, marine craft, and spacecraft. Expert has developed aerospace control systems from concept through flight certification. Applications include…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…
Molecular Diagnostics, Molecular Biology, Public Health
Expert has extensive expertise in molecular diagnostics, particularly for infectious pathogens. He is an expert in test development using state of the art technologies, including real time PCR. He has developed and implemented many tests for the detection of pathogenic…
Business Strategy for Diagnostic Companies
Expert R. Expert has an over 25-year career of international management in the industrial marketplace. Expert has held line responsibility for the creation, implementation, and re-direction of many businesses. These experiences include successes with venture capital backed start-ups, publicly-traded companies,…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Genomics
Expert worked with a team that cloned and expressed the enzyme T4 endonuclease VII for commercial distribution. He developed the basic assay of enzyme activity that was used in optimization and quality control of the enzyme. He is an author…